Ferring Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted approval for the new labeling of the company’s fertility products. The FDA approved MENOPUR and BRAVELLE mixed and administered in a single injection.
The approval makes Ferring’s mixed protocol as the first and only combined IVF stimulation gonadotropins to have regulatory authorization for being mixed and administered together in a single syringe. The FDA approval was based on a pharmacodynamics study which assessed safety and stability of the treatment. Data from the study indicated that the mixed protocol did not interfere with efficient delivery of the indicated dosage of either MENOPUR or BRAVELLE.
Nick Hart, Ferring's Business Unit Head for U.S. Reproductive Health, said “Ferring is excited to provide an IVF treatment option that requires fewer injections. We are pleased with the FDA's response and look forward to offering physicians and patients the ability for customization and a simplified treatment protocol.”
MENOPUR is a prescription drug which contains hormones, specifically follicle stimulating hormone and luteinizing hormone activity. The injected hormones work to stimulate healthy ovaries to produce eggs. MENOPUR administered subcutaneously is intended for the development of multiple follicles and pregnancy in the ovulatory patients involved in an ART program. MENOPUR is indicated for women who need medical help to get pregnant.
BRAVELLE is also a prescription drug containing hormones, in particular follicle stimulating hormone. The drug, administered subcutaneously or intramuscular together with hCG, is indicated for ovulation induction in patients who have experienced pituitary suppression. BRAVELLE is indicated for controlled ovarian stimulation as part of an ART cycle program in patients who have previously undergone pituitary suppression.
The label update for MENOPUR and BRAVELLE is a result of the COMBINE trial conducted by Ferring to demonstrate safety and efficacy of both drugs mixed and administered together in a single injection.